Clip for Implant Deployment Device

ABSTRACT

An instrument for deploying a surgical implant includes a handle, an elongated shaft extending from the handle, and a frame arm. The frame arm includes a clip pair for releasably attaching the surgical implant to the frame arm. The clip pair includes first and second clips operably coupled by a spring member. The first and second clips are repositionable from a closed position to an open position. The spring member biases the first and second clips towards the closed position. A lock bar is coupled to the frame arm and translatable between an unlocked position and a locked position. In the locked position, the lock bar maintains the first and second clips in either the open or the closed position. When the lock bar is in the unlocked position, the first and second clips are freely rotatable between the open and closed positions.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of U.S. patentapplication Ser. No. 13/451,962, filed on Apr. 20, 2012, which is acontinuation-in-part of U.S. patent application Ser. No. 12/891,962,filed on Sep. 28, 2010, which is a continuation-in-part of U.S. patentapplication Ser. No. 12/834,456, filed Jul. 12, 2010, which is acontinuation-in-part of PCT international patent application numberPCT/IL2009/000188, filed Feb. 18, 2009, which claims the benefit of andpriority to U.S. provisional patent application Ser. No. 61/029,386,filed Feb. 18, 2008. The present application also claims the benefit ofand priority to U.S. provisional patent application Ser. No. 61/691,859,filed Aug. 22, 2012, which claims the benefit of and priority to U.S.provisional patent application Ser. No. 61/691,860, filed Aug. 22, 2012,which claims the benefit of and priority to U.S. provisional patentapplication Ser. No. 61/691,863, filed Aug. 22, 2012, which claims thebenefit of and priority to U.S. provisional patent application Ser. No.61/691,864, filed Aug. 22, 2012, which claims the benefit of andpriority to U.S. provisional patent application Ser. No. 61/691,866,filed Aug. 22, 2012, which claims the benefit of and priority to U.S.provisional patent application Ser. No. 61/691,869, filed Aug. 22, 2012.The present application also claims the benefit of and priority to U.S.provisional patent application Ser. No. 61/302,186, filed Feb. 8, 2010.The contents of each of these prior applications are incorporated byreference herein in their entirety.

FIELD OF THE INVENTION

This invention generally relates to a device and method for reversiblycoupling an implant to an implant deployment device.

BACKGROUND

An object of the present invention is to provide an apparatus and amethod for performing corrective surgery on internal wounds such as ahernia where invasion of the patient's body tissues is minimized andresultant trauma is reduced.

A hernia is a protrusion of a tissue, structure, or part of an organthrough the muscular tissue or the membrane by which it is normallycontained. In other words, a hernia is a defect in the abdominal wallthrough which a portion of the intra-abdominal contents can protrude.This often causes discomfort and an unsightly, visible bulge in theabdomen. When such a hernia defect occurs in the abdominal region,conventional corrective surgery has required opening the abdominalcavity by surgical incision through the major abdominal muscles. Whilethis technique provides for effective corrective surgery of the herniadefect, it has the disadvantage of requiring a hospital stay of as muchas a week, during which pain is frequently intense, and it requires anextended period of recuperation. After the conventional surgery,patients frequently cannot return to a full range of activity and workschedule for a month or more. Accordingly, medical science has soughtalternative techniques that are less traumatic to the patient andprovide for more rapid recovery.

Laparoscopy is the science of introducing a viewing instrument through aport into a patient's body, typically the abdominal cavity, to view itscontents. This technique has been used for diagnostic purposes for morethan 75 years. Operative laparoscopy is performed through tiny openingsin the abdominal wall called ports. In most surgical techniques, severalports, frequently three to six, are used. Through one port is insertedthe viewing device, which conventionally comprises a fiber optic rod orbundle having a video camera affixed to the outer end to receive anddisplay images from inside the body. The various surgical instrumentsare inserted through other ports to do the surgery that normally wouldbe performed through an open incision through the abdominal wall.Because the laparoscopic surgical techniques require only very smallholes through the abdominal wall or other portions of the body, apatient undergoing such surgery may frequently leave the hospital withinone day after the surgery and resume a full range of normal activitieswithin a few days thereafter.

In repairing hernia the physician needs to first deploy the implant andthen attach the implant to the tissue.

There are many patents and patent applications relating to attaching aprosthesis implant to a tissue via tacks. Each patent and patentapplication describes a different attachment mechanism via differentanchoring means (see for example U.S. Pat. No. 6,447,524). Traditionalanchors used in surgery include clips, staples, or sutures, and may alsobe referred to as tissue anchors. These devices are usually made of abiocompatible material (or are coated with a biocompatible material), sothat they can be safely implanted into the body.

Most tissue anchors secure the tissue by impaling it with one or moreposts or legs that are bent or crimped to lock the tissue into position.Thus, most traditional anchors are rigid or are inflexibly attached tothe tissue. For example PCT No. WO 07/021834 describes an anchor havingtwo curved legs that cross in a single turning direction to form a loop.Those two curved legs are adapted to penetrate tissue in a curvedpathway. U.S. Pat. No. 4,485,816 describes surgical staple made of shapememory alloy. The staple is placed in contact of the tissue and thenheated. The heating causes the staple to change its shape thus,penetrating the tissue.

U.S. Pat. No. 6,893,452 describes a tissue attachment device thatfacilitates wound healing by holding soft tissue together under improveddistribution of tension and with minimal disruption of the woundinterface and its nutrient supplies.

U.S. Pat. No. 6,517,584 describes a hernia implant which includes atleast one anchoring device made of shape memory material. The anchoringdevices are initially secured to the prosthesis by being interlacedthrough a web mesh constituting the prosthesis. The attachment isobtained by altering the attachment element's shape from rectilinear toa loop shape due to heat induced shape memory effect.

Yet other patent literature relates to devices for endoscopicapplication of surgical staples adapted to attach surgical mesh to abody tissue.

An example of such a teaching is to be found in U.S. Pat. No. 5,364,004;U.S. Pat. No. 5,662,662; U.S. Pat. No. 5,634,584; U.S. Pat. No.5,560,224; U.S. Pat. No. 5,588,581; and in U.S. Pat. No. 5,626,587.

There are a few patent and patent applications teaching the deploymentof implants. For example U.S. Pat. No. 5,836,961 which relates to anapparatus used for developing an anatomic space for laparoscopic herniarepair and an implant for use therewith. The apparatus of U.S. Pat. No.5,836,961 comprises a tubular introducer member having a bore extendingtherethrough. A tunneling shaft is slidably mounted in the bore and hasproximal and distal extremities including a bullet-shaped tip. A roundedtunneling member is mounted on the distal extremity of the tunnelingshaft. The apparatus comprises an inflatable balloon. Means is providedon the balloon for removably securing the balloon to the tunnelingshaft. Means is also provided for forming a balloon inflation lumen forinflating the balloon. The balloon is wrapped on the tunneling shaft. Asleeve substantially encloses the balloon and is carried by thetunneling shaft. The sleeve is provided with a weakened region extendinglongitudinally thereof, permitting the sleeve to be removed whereby theballoon can be unwrapped and inflated so that it lies generally in aplane. The balloon as it is being inflated creates forces generallyperpendicular to the plane of the balloon to cause pulling apart of thetissue along a natural plane to provide the anatomic space.

More patent literature can be found in PCT No. WO 08/065653 whichrelates to a device especially adapted to deploy an implant within abody cavity. The device is an elongate open-bored applicator andcomprises (a) at least one inflatable contour-balloon, (b) at least oneinflatable dissection balloon. The inflatable contour-balloon and theinflatable dissection balloon are adjustable and located at the distalportion. The elongate open-bored applicator additionally comprises (c)at least one actuating means located at the proximal portion. Theactuating means is in communication with the inflatable contour-balloonand the inflatable dissection balloon. The actuating means is adapted toprovide the inflatable contour-balloon and the inflatable dissectionballoon with independent activation and/or de-activation.

Although all the above described patents and patent applicationsdemonstrate attachment means or deployment means, none of the literaturefound relates to a reversible connection device which enable areversible coupling between the implant and the implant deploymentdevice.

Thus, there is still a long felt need for a device that will enable areversible connection between the implant and the implant deploymentdevice.

SUMMARY

It is one object of the present invention to provide an activereversible connection mechanism adapted to provide a reversibleattachment between a prosthetic implant and an implant deploymentdevice, wherein said attachment can be actively reversed withoutrequiring any application of force on said implant.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, wherein said activereversible connection mechanism comprising at least one clip, hinge-likecoupled to said implant deployment device, adapted to attach saidimplant to said implant deployment device: Said clip is characterized byhaving at least three configurations: (i) a horizontal configuration inwhich said clip is substantially horizontal with respect to said implantdeployment device; (ii) a vertical configuration in which said clip issubstantially vertical with respect to said implant deployment device;and, (iii) a free motion configuration in which said clip is free torotate; such that (i) when said clip is in said horizontal configurationsaid attachment between said implant and said implant deployment deviceis obtained; (ii) when said clip is in said free motion configurationsaid detachment between said implant and said implant deployment deviceis obtained.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, additionallycomprising at least one locking bar characterized by at least twoconfigurations: (i) lock configuration in which said lock bar maintainssaid clip in said horizontal configuration; and, (ii) free configurationin which said locking bar enables said clip a free movement.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, wherein said activereversible connection additionally comprising at least one detachmentactuator adapted to reversibly transform said locking bar from said lockconfiguration to said free configuration.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, wherein saidattachment between said implant and said implant deployment device isobtained once said locking bar is in its said lock configuration andsaid at least one clip is in said horizontal configuration such that thesame at least partially penetrates said implant.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, wherein saiddetachment is achieved by transforming said locking bar from said lockconfiguration to said free configuration via said at least onedetachment actuator.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, wherein saiddetachment actuator comprises a wire; further wherein said wire isattached to said lock bar.

It is another object of the present invention to provide the activereversible connection mechanism as defined above, wherein saidtransformation of said clip from said vertical configuration into theirsaid horizontal configuration is performed manually by the physician orby the aid of a dedicated device.

It is another object of the present invention to provide a method forattaching a prosthetic implant to an implant deployment device. Themethod comprising steps selected, inter alia, from:

a. obtaining an active reversible connection mechanism adapted toprovide a reversible attachment between said prosthetic implant and saidimplant deployment device; wherein said attachment can be activelyreversed without requiring any application of force on said implant;said active reversible connection comprising

i. at least one clip, hinge-like coupled to said implant deploymentdevice, adapted to attach said implant to said implant deploymentdevice: Said clip is characterized by having at least threeconfigurations: (i) horizontal configuration in which said clip issubstantially horizontal with respect to said implant deployment device;(ii) a vertical configuration in which said clip is substantiallyvertical with respect to said implant deployment device; and, (iii) afree motion configuration in which said clip is free to rotate;

ii. at least one locking bar characterized by at least twoconfigurations: (i) lock configuration in which said lock bar maintainssaid clip in said horizontal configuration; and, (ii) free configurationin which said locking bar enables said clip a free movement; and,

b. providing said clips in said vertical configuration;

c. providing said locking bar in said lock configuration;

d. threading said implant through said clip;

e. transforming said clip into its said horizontal configuration therebyproviding said attachment between said implant and said implantdeployment device;

It is another object of the present invention to provide the method asdefined above, additionally comprising the step of providing said activereversible connection with at least one detachment actuator.

It is another object of the present invention to provide the method asdefined above, additionally comprising the step of reversiblytransforming said locking bar from said lock configuration to said freeconfiguration via said detachment actuator; thereby enabling freerotation of said clip such that detachment between said implant and saidimplant deployment device is obtained.

It is another object of the present invention to provide the method asdefined above, additionally comprising the step of introducing saidimplant deployment device into a body cavity.

It is another object of the present invention to provide the method asdefined above, additionally comprising the step of detaching saidimplant from said implant deployment device.

It is another object of the present invention to provide the method asdefined above, wherein said detachment additionally comprising the stepsof reversibly transforming said locking bar from said lock configurationto said free configuration via said detachment actuator; therebyenabling said clip to rotate freely such that said detachment betweensaid implant and said implant deployment device is obtained.

It is another object of the present invention to provide a hernia kituseful in minimal invasive hernia surgery, comprising:

a. an implant;

b. an implant deployment device, adapted to deploy said implant withinthe abdominal cavity; and,

c. an active reversible connection mechanism for reversible attachingsaid implant to said implant deployment device;

wherein attachment can be actively reversed without requiring anyapplication of force on said implant.

It is another object of the present invention to provide the hernia kitas defined above, wherein said active reversible connection mechanismcomprising:

a. at least one clip, hinge-like coupled to said implant deploymentdevice, adapted to attach said implant to said implant deploymentdevice: Said clip is characterized by having at least threeconfigurations: (i) horizontal configuration in which said clip issubstantially horizontal with respect to said implant deployment device;(ii) a vertical configuration in which said clip is substantiallyvertical with respect to said implant deployment device; and, (iii) afree motion configuration in which said clip is free to rotate; suchthat (i) when said clip is in said horizontal configuration saidattachment between said implant and said implant deployment device isobtained; (ii) when said clip is in said free motion configuration saiddetachment between said implant and said implant deployment device isobtained.

It is another object of the present invention to provide the hernia kitas defined above, additionally comprising at least one locking barcharacterized by at least two configurations: (i) lock configuration inwhich said lock bar maintains said clip in said horizontalconfiguration; and, (ii) free configuration in which said locking barenables said clip a free movement.

It is another object of the present invention to provide the hernia kitas defined above, wherein said active reversible connection additionallycomprising at least one detachment actuator adapted to reversiblytransform said locking bar from said lock configuration to said freeconfiguration.

It is another object of the present invention to provide the hernia kitas defined above, wherein said attachment between said implant and saidimplant deployment device is obtained once said locking bar is in itssaid lock configuration and said at least one clip is in said horizontalconfiguration such that the same at least partially penetrates saidimplant.

It is another object of the present invention to provide the hernia kitas defined above, wherein said detachment is achieved by transformingsaid locking bar from said lock configuration to said free configurationvia said at least one detachment actuator.

It is still an object of the present invention to provide the hernia kitas defined above, wherein said detachment actuator comprises a wire;further wherein said wire is attached to said lock bar.

It is an object of the present invention to provide the hernia kit asdefined above, wherein said transformation of said clip from saidvertical configuration into their said horizontal configuration isperformed manually by the physician or by the aid of a dedicated device.

At least one aspect of this disclosure includes a system for closing anaperture in a biological tissue, the system comprising a proximalportion adapted to remain outside the body, a distal portion adapted tobe inserted into the body, the distal portion including at least oneframe arm, and at least one clip pair connected to the at least oneframe arm and configured to releasably retain a surgical implant,wherein each clip pair includes two clips, each clip including a hook, abody, a hinge hole, and at least one spring member integrally connectedto each clip, wherein the spring member biases each clip from an openposition towards a closed position.

In at least one aspect of this disclosure, the at least one springmember is integrally connected to the hook.

In at least one aspect of this disclosure, the at least one springmember is integrally connected to the body.

In at least one aspect of this disclosure, each clip further includes alocking tab, wherein the at least one spring member is integrallyconnected to the locking tab.

In at least one aspect of this disclosure, the at least one springmember includes a single bend shape.

In at least one aspect of this disclosure, the at least one springmember includes a multiple bend shape.

In at least one aspect of this disclosure, the at least one springmember exists entirely in a plane defined by a rotation of the clips.

In at least one aspect of this disclosure, wherein the at least aportion of the at least one spring member exists outside a plane ofrotation of the clips.

In at least one aspect of this disclosure, at least one clip is made ofnitinol.

In at least one aspect of this disclosure, a clip system for releasablyretaining a mesh to an implant deployment device includes at least oneclip pair connectable to the implant deployment device and configured toreleasably retain a surgical implant, wherein each clip pair includestwo clips, each clip including a hook, a body, a hinge hole, and atleast one spring member integrally connected to each clip, wherein thespring member biases each clip from an open position towards a closedposition.

In at least one aspect of this disclosure, the at least one springmember is integrally connected to the hook.

In at least one aspect of this disclosure, the at least one springmember is integrally connected to the body.

In at least one aspect of this disclosure, each clip further includes alocking tab, wherein the at least one spring member is integrallyconnected to the locking tab.

In at least one aspect of this disclosure, the at least one springmember includes a single bend shape.

In at least one aspect of this disclosure, the at least one springmember includes a multiple bend shape.

In at least one aspect of this disclosure, the at least one springmember exists entirely in a plane defined by rotation of the clips.

In at least one aspect of this disclosure, the at least a portion of theat least one spring member exists outside a plane of rotation of theclips.

In at least one aspect of this disclosure, at least one clip is made ofnitinol.

In at least one aspect of this disclosure, a clip system for releasablyretaining a mesh to an implant deployment device includes at least oneclip pair connectable to the implant deployment device and configured toreleasably retain a surgical implant, wherein each clip pair includestwo clips, each clip including a hook, a body, a hinge hole, and aspring member integrally connected to each clip, wherein the springmember is integrally connected to the hook on each clip, wherein thespring member biases each clip from an open position towards a closedposition.

In at least one aspect of this disclosure, the clip pair comprisesnitinol.

In at least one aspect of this disclosure, a method for deploying asurgical implant at a target site includes providing at least onesurgical implant deployment device including at least one clip pairconnectable to the surgical implant deployment device and configured toreleasably retain a surgical implant, wherein each clip pair includestwo clips, each clip including a hook, a body, a hinge hole, and aspring member integrally connected to each clip, wherein the springmember biases each clip from an open position towards a closed position,attaching a surgical implant to the surgical implant deployment devicewhen the clips are in an open position, and allowing the spring memberto force each clip into a closed position thereby compressing thesurgical implant to the surgical implant deployment device.

In at least one aspect of this disclosure, the method further includesinserting at least a portion of the surgical implant deployment deviceinto an opening in tissue.

In at least one aspect of this disclosure, the method further includesseparating the surgical implant from the at least one clip pair bymoving the surgical implant device relative to the implant deploymentdevice.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, withreference to the accompanying drawings, wherein:

FIG. 1A illustrates an example of an implant deployment device whichcomprises said active reversible connection mechanism;

FIGS. 2A-2D illustrate the internal operation of said active reversibleconnection mechanism;

FIGS. 3A-3E illustrate a method of using said active reversibleconnection mechanism for providing said reversible connection betweensaid implant and said implant deployment device;

FIG. 4A-4H illustrate an embodiment of a stapling apparatus adapted forproviding a reversible connection by the active reversible connectionmechanism;

FIG. 5 illustrates an embodiment of a staple return spring;

FIG. 6 illustrates an embodiment of a clip pair in accordance with thepresent disclosure;

FIG. 7 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 8 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 9 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 10 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 11 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 12 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 13 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 14 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 15 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 16 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 17 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 18 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 19 illustrates another embodiment of a clip pair in accordance withthe present disclosure;

FIG. 20 is a side perspective view of another embodiment of a lock barin accordance with the present disclosure;

FIG. 21A is a side perspective view of a frame arm with the clip pair ofFIG. 8 in a closed position and the lock bar of FIG. 20 in an unlockedposition according to the present disclosure;

FIG. 21B is a side perspective view of the embodiment of FIG. 21A withthe clip pair in an open position and the lock bar in a locked position;and

FIG. 21C is a side perspective view of the embodiment of FIG. 21A withthe clip pair in the closed position and the lock bar in the lockedposition.

DETAIL DESCRIPTION OF THE SPECIFIC EMBODIMENTS

The following description is provided, alongside all chapters of thepresent invention, so as to enable any person skilled in the art to makeuse of the invention and sets forth the best modes contemplated by theinventor of carrying out this invention. Various modifications of thepresent disclosure should be apparent to those skilled in the art, sincethe generic principles of the present invention have been definedspecifically to provide means and method for creating a reversible andactive connection between an implant and an implant deployment device.

The present invention provides an active reversible connection mechanismbetween a prosthetic implant and an implant deployment device whereinsaid connection can be performed during a surgery at a standard surgeryroom by the medical staff

Furthermore, the present invention provides means so as to enable thesurgeon to actively eliminate said attachment once detachment betweensaid implant deployment device and said implant is necessary.

It should be emphasized that some of the major advantages of the presentinvention, with respect to the prior art, is to provide a fast andintuitive method for creating a reliable connection between an implantand an implant deployment device in the surgery room. Embodiments of animplant include, but are not limited to, a surgical patch, a surgicalmesh, or other biocompatible implants usable in repairing a defect inbody tissue.

In addition, the present invention provides means to actively disconnectsaid implant from said implant deployment device, when saiddisconnection is desired without the need to exert large forces on saidimplant and/or said tissue.

The term “Hernia” refers hereinafter for umbilical hernia, hiatalhernia, ventral hernia, postoperative hernia, epigastric hernia,spiegelian hernia, inguinal hernia and femoral hernia, generally anyabdominal wall related hernia.

The term “hinge” or “hinge-like connection” refers hereinafter as to atype of bearing that connects two solid objects, typically allowing onlya limited angle of rotation between them. Two objects connected by anideal hinge rotate relative to each other about a fixed axis of rotation(the geometrical axis of the hinge). Hinges may be made of flexiblematerial or of moving components.

The term “hinge like connection” can refer to a standard hinge or to aliving hinge (i.e., a thin flexible hinge (flexure bearing) made fromplastic that joins two rigid parts together while allowing them to bendalong the line of the hinge).

The term “controlled deployment” refers hereinafter to an implantdeployment which is continuous. Thus, deployment using the presentlydisclosed implant deployment device is variable amongst a number ofdeployment levels between a fully opened position and a fully closedposition rather than a binary arrangement that does not include anyintermediate positions or levels between fully opened and fully closed.This is in contrast to some conventional deployment systems in which thedeployment of the implant relies upon the elasticity of a loop membersurrounding the implant such that the implant can be either fully foldedor fully unfolded. No intermediate stages are enabled. In the presentinvention, there can be several deployment stages.

The term “bidirectional” or “fully reversible deployment” refershereinafter to the deployment of the implant, which according to thepresent invention, is fully reversible. In other words, the implantdeployment is bidirectional, i.e., the implant can be fully folded(i.e., deployed within the body) and then, if the surgeon desires, theimplant can be fully unfolded simply by the reconfiguration of theflexible arms from the initial stage to the final stage and vice versa.

The term “minimally invasive surgery” refers hereinafter to proceduresthat avoid open invasive surgery in favor of closed or local surgerywith fewer traumas. Furthermore, the term refers to a procedure that iscarried out by entering the body through the skin or through a bodycavity or anatomical opening, but with the smallest damage possible.

The term “articulation” refers hereinafter to a joint or juncturebetween two segments of the device. The articulating means of thepresent invention provides the ability to better adjust the device tothe curvature of the treated tissue.

The term “orientation” refers hereinafter to the rotation of the meshwithin the abdominal cavity so as to fit to the hernia. Usually the meshis not symmetric in shape (e.g., rectangular or elliptical)—therefore ithas different directions. By rotating the mesh within the abdominalcavity—one can decide which direction is turned where.

The term “adjusting” refers hereinafter to rolling, folding, and windingof the implant, thus preparing and enabling the insertion of saidimplant into the abdominal cavity.

The term “active reversible connection” refers hereinafter to a couplingbetween the implant and the implant deployment device implant deploymentdevice in which the coupling/decoupling between the implant and theimplant deployment device is enabled by an act performed by the user(namely the physician). Once said user performed said act, saidcoupling/decoupling is canceled.

According to the present invention the coupling/decoupling is obtainedactively via the aid of dedicated clips which are characterized by atleast two configurations:

(a) substantially horizontal/parallel configuration (in which anattachment between the implant and the implant deployment device isprovided);

(b) substantially vertical configuration; and,

(c) a configuration in which the clips are free to rotate.

Before explaining the figures, it should be understood that theinvention is not limited in its application to the details ofconstruction and the arrangement of the components set forth in thefollowing description or illustrated in the drawings. The invention canbe carried out in various ways.

Reference is now being made to FIG. 1A illustrates an example of animplant deployment device 100 which comprises said active reversibleconnection mechanism.

Implant deployment device 100 is defined hereinafter as a surgicaldevice which can introduce an implant into a body cavity of a patient;implant deployment device 100 can deploy said implant such that it is atleast partially spared inside the body cavity; alternatively implantdeployment device 100 can only introduce said implant into the bodycavity without performing any deployment.

In general, implant deployment device 100 comprises at least twoportions: a distal portion 101 and a proximal portion 102. The proximalportion is adapted to remain outside the body, adjacently to the userand the distal portion 101 is adapted to be inserted into the body.

The distal portion comprises at least one frame arm 104 to which theimplant is attached. Each frame arm 104 comprises said active reversibleconnection mechanism which provides reversible attachment between eachframe arm 104 and the implant 106 such that said implant can berolled/folded on said distal portion 101, and inserted into thepatient's body cavity through a laparoscopic cannula or a smallincision.

It should be noted that the term reversible refers hereinafter to theability to both attach the implant to the implant deployment device andto decouple the same from the implant deployment device.

Said active reversible connection mechanism comprises at least one clip107. Said clip is coupled to said frame arm 104 by hinge tab 132. Saidactive reversible connection is covered by cover 131 which is attachedto the frame arm 104. Cover 131 comprises at least one hinge tab 132which is adapted to hold said clip 107 attached to frame arm 104 an toserve as a hinge allowing free rotation of said clip 107. Said hinge tab132 is inserted through hinge hole 133, located at clip 107 and throughhole 134, located at frame arm 104.

Reference is now being made to FIGS. 2A-2D which illustrate the internaloperation of said active reversible connection mechanism. For thepurpose of illustration only, cover 131 is removed from these drawings.

A locking bar 203 is located inside groove 204 at frame arm 104. Saidlocking bar 203 can move linearly inside said groove 204 and comprisesat least one groove 205. Said locking bar 203 is characterized by atleast two positions: free position, in which each of said groove/s 205is substantially located below said clip 107 (see FIGS. 2C and 2D), andlock position, in which said groove 205 is located away from said clip107 (see FIGS. 2A and 2B).

In the lock position of the locking bar 203, the clip 107 aresubstantially perpendicular to the frame arm 104; and in free positionof the locking bar 203, the clip 107 are free to rotate (hence, as willbe discussed hereinafter a detachment is enabled).

A disconnection wire 206 is attached to said locking bar 203. Said wire206 can be pulled proximally to the proximal portion 102 and is adaptedto transform said locking bar 203 from its said lock position into itssaid free position.

According to this embodiment, each clip 107 comprises at least 3sections: protruding portion (PP) 201 adapted to protrude through saidimplant during said connection process, hinge hole 133, and locking tab202 which is tilted toward frame arm 104.

Each of said clip 107 is characterized by at least two configurations:horizontal/parallel configuration in which said clip 107 issubstantially horizontal and parallel to said frame arm 104 (FIGS. 2B,2C) and vertical configuration in which said clip 107 is substantiallyvertical with respect to said frame arm 104 (FIGS. 2A and 2D).

At least one holding hole 207 is located at said locking bar 203 and isadapted to hold said clip 107 in its vertical configuration.

At least one niche 208 in located at frame arm 104 adapted toaccommodate said locking tab 202 of said clip 107 while the clip 107 isin its said horizontal/parallel configuration.

Reference is now being made to FIGS. 3A-3D illustrating a method ofusing said active reversible connection mechanism in order to providesaid reversible connection between said implant and said implantdeployment device 100. Again, for the purpose of illustration only,cover 131 was removed from these drawings.

FIG. 3A illustrates the initial state of said active reversibleconnection mechanism in which all of said clip 107 are in their verticalconfiguration and said locking bar 203 is positioned in said lockposition.

As can be seen in the figure, said locking tab 202 of each said clip 107is located inside said holding hole 207, therefore each clip 107 is heldin its said vertical configuration and can penetrate an implant 210whilst the last is mounted on top of said implant deployment device (seeFIG. 3B).

Once said implant is mounted, each of said clip 107 is transformed fromsaid vertical configuration into their said horizontal configuration(see FIG. 3C).

Said transformation can be achieved either manually (i.e., the physicianwill manually rotate the clips 107 thereby transforming them from saidvertical configuration into their said horizontal configuration) or bythe aid of a dedicated device.

Once said clip 107 is transformed to its horizontal configuration whilesaid locking bar is in its said lock position, said locking tab 202 isurged into niche 208. Since the locking tab 202 is titled inwardly, ifsaid clip 107 is pulled upwardly in this state, the locking tab 202 isstopped by the upper edge of said locking bar 203, therefore, therotation back to said vertical configuration of said clip 107 is limitedby said locking bar 203 and said clips 107 are locked in said horizontalconfiguration, holding said implant attached to said frame arm 104.

It should be pointed out that it is a unidirectional mechanism. In otherwords, if one tries to force clips 107 to its vertical configuration,locking tabs 202 will ‘bump into locking bar 203.

By further pulling said locking bar 203 towards the proximal portion theclips 107 are unlocked and can be rotated be back to its verticalconfiguration (see FIGS. 3D and 3E).

Once detachment between said implant 210 and said implant deploymentdevice in desired, locking bar 203 is pulled backward by wire 206,changing the position of said locking bar form its said lock positioninto its said free position (see FIG. 3D). In said free position of thelocking bar 203, the clips 107 are free to rotate (hence, as will bediscussed hereinafter, a detachment between the implant deploymentdevice and the implant is enabled).

Once locking bar 203 is positioned in said free position, said groove's205 is located below said clips 107, therefore said locking bar 202 isno longer limiting the movement of said clips 107 enabling their freemovement. In this state, detachment can be obtained by simply pullingsaid frame arm 104 away from said implant; as a result, said clips 107rotate back into their said vertical configuration and are released fromsaid implant (see FIG. 2E).

Reference is now made to FIG. 4A-4H, which illustrate an embodiment of astapling apparatus 400 adapted for providing said reversible connectionby said active reversible connection mechanism. Said stapling apparatus400 comprises a frame 401 which holds the distal portion 101 of animplant deployment device 100. Four staplers 403 are connected to theframe 401 at each cornet by four separate hinges (either standard orliving hinges). Each said stapler 403 is adapted to push down theimplant 210 through a pair of clip 107 and to transform said clips 107from a vertical position into a horizontal position (thus providing saidreversible connection). Stapling presses 404 are located at the end ofeach stapler inside groove 405 and adapted to push clip 107 intohorizontal position. Each pair of staplers 403 is connected via bridge407 in order to prevent lateral movement of said staplers 403 during thestapling process. A snap groove 406 is located at the center of theframe 401 and adapted to reversibly hold said implant deployment device100 attached to stapling apparatus 400 until said reversible attachmentis obtained.

Each pair of clip 107 is held in a vertical position by clip holder 402.Each said clip holder 402 is adapted to hold a pair of clip 107 invertical position in order to allow its insertion through the implant210 during the stapling process. In addition, clip holder 402 is adaptedthe hold the clips vertical during shipment in order to allow staplingin the operation room without the need of any preparation. Asillustrated in FIGS. 4B-4C, each clip holder 402 comprises two grooves408 which hold the clip 107 in a vertical position. Once staplingprocess is performed and the surgeon is lowering the stapler 403 towardthe implant, each clip holder 402 is pushed down and as a result it isalso moving laterally. In this state, since the clip 107 are extractedfrom groves 408, their transformation from vertical into horizontalposition is enabled; said lateral movement of said clip holder 402 isobtained as bulge 409 at clip holder 402 is sliding along bulge 410 atthe stapling frame 401 during the down movement of clip holder 402.

FIGS. 4D-4G illustrate the process of connecting the implant 210 to onepair of clip. At the initial stage (FIG. 4D), the clips are heldvertically by clip holder 402. Next, an implant 210 is places on top ofthe stapling apparatus (FIG. 4E); the stapler 403 is then lowered towardthe implant 210 by the surgeon (or other member of the medical staff);as a result the two clip 107 are penetrating through implant 210 andinto groove 405 (FIG. 4F). During the initial penetration, clip 107 isheld by clip holder 402, thus premature transformation from verticalinto horizontal position is prevented. Once the clip 107 are completelyinserted into said implant 210, clip holder 402 is positioned laterallyrelative to the clip 107 (as also described is FIGS. 4B-4C); at thisstage the surgeon push on stapler press 404 and lower it toward clip 107(FIG. 4G), as a result clip 107 position is transformed form verticalposition into horizontal position. Since the said lock bar 203 islocated at its said lock position, once clip 107 are substantiallyhorizontal position, they are locked in this stage, thus providing saidreversible connection between implant 210 and implant deployment device100. Once said connection is obtain with all clip 107, implantdeployment device is removed from SA 400.

FIG. 4H illustrates the configuration of stapling apparatus 400 duringshipment. In order to reduce package volume during shipment and to keepthe device ready for stapling, at least one, preferably two, packagingcaps 411 are utilized. Said caps 411 are reversibly attached to theframe 401, and adapted to retain stapler 403 in a substantiallyhorizontal position during device shipment. In addition, said caps 411also prevent down movement of stapler press 404, prevent lateralmovement of clip holder 402 and prevent non-deliberate extraction ofimplant deployment device 100 from frame 401.

Once the device in removed from its packaging during the surgery, saidpack caps 411 are removed by the medical staff in order to allowstapling of the implant 210 to the implant deployment device 100. Oncethe caps 411 are removed, the staplers 403 springs into horizontalposition allowing the placement of implant 210 onto the staplingapparatus 400 and implant deployment device 100.

In order to allow tight spreading of the implant 210 during surgery,said stapling process is preformed while implant deployment device 100is not completely opened; as a result, once implant deployment device iscompletely opened inside the abdominal cavity, it is stretched beyondits original dimension (as was during stapling) therefore tightspreading is obtained.

Reference is now being made to FIG. 5 which illustrates an embodiment ofa staple return spring 500. In general, staple return spring 500 isneeded in order to return clip 107 into horizontal position immediateafter detachment from the implant 210; this is necessary in orderprevent damage to internal organs by the sharp tip of clip 107 and inorder to prevent clip 107 from being caught at the trocar or at thetissue during device extraction.

FIGS. 6-19 illustrate embodiments of clip pairs that are usable with thepresently disclosed implant deployment device 100. The severalembodiments of the clip pairs are operable with the lock bar 203 (FIG.2A) or lock bar 203 a (FIG. 20) as will be described more fullyhereinafter.

Referring initially to FIG. 6, an embodiment of a clip pair 600 for usewith an implant deployment device 100 (FIG. 1) is illustrated. The clippairs as herein described in this and future embodiment may be used toreplace, or used in conjunction with other pairs of clips 107 of FIG.2A-2D as described above. Clip pair 600 includes two clips 601, eachclip 601 including a hook 603, similar to the protruding portion 201(FIGS. 2A-D) as described above, a body 605, a locking tab 607 similarto locking tab 202 (FIGS. 2A-D) as described above, and a hinge hole 611similar to hinge hole 133 (FIGS. 2A-D) as described above. The clip pair600 also includes a spring member 609 connecting each clip 601 togetherand configured to provide a restoring force to move the clips 601 froman open position towards a closed position. As herein described withrespect to this and future embodiments, an open position is any positionwhere the hooks as herein described are not in contact with or closeproximity to the frame arm 104, and a closed position is where the hooksare in contact with or close proximity to the frame arm to clamp adesired implant.

As is with this embodiment and future embodiments described herein, arestoring force is created by the spring member 609 due to a materialdeformation or bending of the spring member 609 when the clips 601 arerotated toward each other to an open position. As the spring member 609bends, the material forming the spring member 609 resists a change inshape and produces a force in the opposite direction. By holding theclips 601 in an open position, potential energy is stored in thedeformed spring member 609, thus allowing a selective return to theclosed position.

The spring member 609 may take any suitable shape capable of providing aspring force against the clips 601 when at least one of the hooks 603 isrotated upward away from the frame arm 104 (FIG. 2A-D) to an openposition (See FIG. 2A). As shown in FIG. 6, spring member 609 isintegrally connected to the locking tab 607 of each clip 601 of the clippair 600, and has a single bend U-shape. The clip pair 600 may be madefrom any suitable semi-rigid material, including but not limited to anickel titanium shape memory alloy such as nitinol.

The shape and number of bends of this spring member 609 and othersherein described effects the overall spring constant of the system,allowing a user to select a desired spring member that produces adesired restoring force in an open position.

In the embodiment as shown in FIG. 6, spring member 609 will tend tobend outwardly and downwardly when the clips 601 are moved to an openposition, deforming the spring member 609 and causing the spring member609 to pull on the locking tabs 607 to provide a restoring force to biasthe clips 601 towards a closed position.

Referring to FIG. 7 an embodiment of a clip pair 700 for use with animplant deployment device 100 is illustrated. Clip pair 700 includes twoclips 701, each clip 701 including a hook 703, similar to the protrudingportion 201 (FIGS. 2A-D) as described above, a body 705, a locking tab707 similar to locking tab 202 (FIGS. 2A-D) as described above, and ahinge hole 711 similar to hinge hole 133 (FIGS. 2A-D) as describedabove. The clip pair 700 also includes a spring member 709 connectingeach clip 701 together and configured to provide a restoring force tomove the clips 701 from an open position towards a closed position. Thespring member 709 may take any suitable shape capable of providing aspring force against the clips 701 when at least one of the hooks 703 isrotated upward away from the frame arm 104. As shown in FIG. 7, springmember 709 is integrally connected to the locking tab 707 of each clip701 of the clip pair 700, and has a two bend circular curved shape. Theclip pair 700 may be made from any suitable semi-rigid material,including but not limited to a nickel titanium shape memory alloy suchas nitinol.

In the embodiment as shown in FIG. 7, spring member 709 will tend tobend outwardly and downwardly when the clips 701 are moved to an openposition, deforming the spring member 709 and causing the spring member709 to pull on the locking tabs 707 to provide a restoring force to biasthe clips 701 to a closed position. As opposed to the embodiment of FIG.6, the spring member 709 may bend and function differently as a resultof the added bends and the circular shape.

Referring to FIG. 8, an embodiment of a clip pair 800 for use with animplant deployment device 100 is illustrated. Clip pair 800 includes twoclips 801, each clip 801 including a hook 803, similar to the protrudingportion 201 (FIGS. 2A-D) as described above, a body 805 having a lockingportion 807 similar in function to locking tab 202 (FIGS. 2A-D) asdescribed above, and a hinge hole 811 similar to hinge hole 133 (FIGS.2A-D) as described above. The clip pair 800 also includes a springmember 809 connecting each clip 801 together and configured to provide arestoring force to move the clips 801 from an open position towards aclosed position. The spring member 809 may take any suitable shapecapable of providing a spring force against the clips 801 when at leastone of the hooks 803 is rotated upward away from the frame arm 804. Asshown in FIG. 8, spring member 809 is integrally connected to a topsurface of locking tab 807 or body 805 of each clip 801 of the clip pair800, and has a single bend circular curved shape. The clip pair 800 maybe made from any suitable semi-rigid material, including but not limitedto a nickel titanium shape memory alloy such as nitinol.

In the embodiment as shown in FIG. 8, spring member 809 will tend to bowoutwardly when the clips 801 are moved to an open position, deformingthe spring member 809 and causing the spring member 809 to pull on theconnection point to the clips 801 (at the locking tabs 807 or body 805)to provide a restoring force to bias the clips 801 to a closed position.

Referring to FIG. 9, an embodiment of a clip pair 900 for use with animplant deployment device 100 is illustrated. Clip pair 900 includes twoclips 901, each clip 901 including a hook 903, similar to the protrudingportion 201 (FIGS. 2A-D) as described above, a body 905 having a lockingportion 907 similar in function to locking tab 202 (FIGS. 2A-D) asdescribed above, and a hinge hole 911 similar to hinge hole 133 (FIGS.2A-D) as described above. The clip pair 900 also includes a springmember 909 connecting each clip 901 together, and configured to providea restoring force to move the clips 901 from an open position towards aclosed position. The spring member 909 may take any suitable shapecapable of providing a spring force against the clips 901 when at leastone of the hooks 903 is rotated upward away from the frame arm 904. Asshown in FIG. 9, spring member 909 is integrally connected to a topsurface of locking portion 907 or body 905 of each clip 901 of the clippair 900, and has a single bend U-shape with an elongated backspan. Theclip pair 900 may be made from any suitable semi-rigid material,including but not limited to a nickel titanium shape memory alloy suchas nitinol.

In the embodiment as shown in FIG. 9, spring member 909 will tend to bowoutwardly when the clips 901 are moved to an open position, deformingthe spring member 909 and causing the spring member 909 to pull on theconnection point to the clips 901 (at the locking tabs 907 or body 905)to provide a restoring force to bias the clips 901 towards a closedposition. As opposed to the embodiment of FIG. 8, the spring member 909may be varied as a result of the added bends such that spring member 909may fold outwardly.

Referring to FIG. 10, an embodiment of a clip pair 1000 for use with animplant deployment device 100 is illustrated. Clip pair 1000 includestwo clips 1001, each clip 1001 including a hook 1003, similar to theprotruding portion 201 (FIGS. 2A-D) as described above, a body 1005having a locking portion 1007 similar in function to locking tab 202(FIGS. 2A-D) as described above, and a hinge hole 1011 similar to hingehole 133 (FIGS. 2A-D) as described above. The clip pair 1000 alsoincludes a spring member 1009 connecting each clip 1001 together, andconfigured to provide a restoring force to move the clips 1001 from anopen position towards a closed position. The spring member 1009 may takeany suitable shape capable of providing a spring force against the clips1001 when at least one of the hooks 1003 is rotated upward away from theframe arm 1004. As shown in FIG. 10, spring member 1009 is integrallyconnected to a top surface of locking portion 1007 at an end of thelocking portion 1007 of each clip 1001 of the clip pair 1000. The springmember 1009 has a single bend U-shape. The clip pair 1000 may be madefrom any suitable semi-rigid material, including but not limited to anickel titanium shape memory alloy such as nitinol.

In the embodiment as shown in FIG. 10, spring member 1009 will tend tobend outwardly and downwardly when the clips 1001 are moved to an openposition, deforming the spring member 1009 and causing the spring member1009 to pull on the locking portions 1007 to provide a restoring forceto bias the clips 1001 towards a closed position.

Referring to FIG. 11, an embodiment of a clip pair 1100 for use with animplant deployment device 100 is illustrated. Clip pair 1100 includestwo clips 1101, each clip 1101 including a hook 1103, similar to theprotruding portion 201 (FIGS. 2A-D) as described above, a body 1105having a locking portion 1107 similar in function to locking tab 202(FIGS. 2A-D) as described above, and a hinge hole 1111 similar to hingehole 133 (FIGS. 2A-D) as described above. The clip pair 1100 alsoincludes a spring member 1109 connecting each clip 1101 together, andconfigured to provide a restoring force to move the clips 1101 from anopen position towards a closed position. The spring member 1109 may takeany suitable shape capable of providing a spring force against the clips1101 when at least one of the hooks 1103 is rotated upward away from theframe arm 1104. As shown in FIG. 11, and similar to the embodiment ofFIG. 10, spring member 1109 is integrally connected to a top surface oflocking portion 1107 at an end of the locking portion 1107 of each clip1101 of the clip pair 1100. The spring member 1109 has a single bendU-shape and is elongate upward as compared to the embodiment of FIG. 10.The clip pair 1100 may be made from any suitable semi-rigid material,including but not limited to a nickel titanium shape memory alloy suchas nitinol.

Similar to the embodiment of FIG. 10, in the embodiment as shown in FIG.11, spring member 1109 will tend to bend outwardly and downward when theclips 1101 are moved to an open position, deforming the spring member1109 and causing the spring member 1109 to pull on the locking tabs 1107to provide a restoring force to bias the clips 1101 towards a closedposition. The degree to which spring member 1101 deforms and therestoring force provided thereby may be greater than the spring member1001 due to the added length of the spring member 1101.

Referring to FIG. 12, an embodiment of a clip pair 1200 for use with animplant deployment device 100 is illustrated. Clip pair 1200 includestwo clips 1201, each clip 1201 including a hook 1203, similar to theprotruding portion 201 (FIGS. 2A-D) as described above, a body 1205having a locking portion 1207 similar in function to locking tab 202(FIGS. 2A-D) as described above, and a hinge hole 1211 similar to hingehole 133 (FIGS. 2A-D) as described above. The clip pair 1200 alsoincludes a spring member 1209 connecting each clip 1201 together, andconfigured to provide a restoring force to move the clips 1201 from anopen position towards a closed position. The spring member 1209 may takeany suitable shape capable of providing a spring force against the clips1201 when at least one of the hooks 1203 is rotated upward away from theframe arm 1204. As shown in FIG. 12, spring member 1209 is integrallyconnected to a top surface of hooks 1203 of each clip 1201 of the clippair 1200, and may have a multiple or single bend configuration. Theclip pair 1200 may be made from any suitable semi-rigid material,including but not limited to a nickel titanium shape memory alloy suchas nitinol.

In the embodiment as shown in FIG. 12, spring member 1209 will tend tobow downward and inward when the clips 1201 are moved to an openposition, deforming the spring member 1209 and causing the spring member1209 to push on the hooks 1203 to provide a restoring force to bias theclips 1201 towards a closed position.

Referring to FIG. 13, an embodiment of a clip pair 1300 for use with animplant deployment device 100 is illustrated. Clip pair 1300 includestwo clips 1301, each clip 1301 including a hook 1303, similar to theprotruding portion 201 (FIGS. 2A-D) as described above, a body 1305, alocking tab 1307 similar to locking tab 202 (FIGS. 2A-D) as describedabove, and a hinge hole 1311 similar to hinge hole 133 (FIGS. 2A-D) asdescribed above. The clip pair 1300 also includes a spring member 1309connecting each clip 1301 together, and configured to provide arestoring force to move the clips 1301 from an open position towards aclosed position. The spring member 1309 may take any suitable shapecapable of providing a spring force against the clips 1301 when at leastone of the hooks 1303 is rotated upward away from the frame arm 1304. Asshown in FIG. 13, spring member 1309 is integrally connected to thelocking tabs 1307 of each clip 1301 of the clip pair 1300, and has amultiple U-bend shape. The clip pair 1300 may be made from any suitablesemi-rigid material, including but not limited to a nickel titaniumshape memory alloy such as nitinol.

In the embodiment as shown in FIG. 13, spring member 1309 will tend tobend outwardly and fold inward similar to an accordion when the clips1301 are moved to an open position, deforming the spring member 1309 andcausing the spring member 1309 to pull on the locking tabs 1307 toprovide a restoring force to bias the clips 1301 towards a closedposition.

Referring to FIG. 14, an embodiment of a clip pair 1400 for use with animplant deployment device 100 is illustrated. Clip pair 1400 includestwo clips 1401, each clip 1401 including a hook 1403, similar to theprotruding portion 201 (FIGS. 2A-D) as described above, a body 1405having a locking portion 1407 similar in function to locking tab 202(FIGS. 2A-D) as described above, and a hinge hole 1411 similar to hingehole 133 (FIGS. 2A-D) as described above. The clip pair 1400 alsoincludes a spring member 1409 connecting each clip 1401 together, andconfigured to provide a restoring force to move the clips 1401 from anopen position towards a closed position. The spring member 1409 may takeany suitable shape capable of providing a spring force against the clips1401 when at least one of the hooks 1403 is rotated upward away from theframe arm 1404. As shown in FIG. 14, spring member 1409 is integrallyconnected to a top surface of hooks 1403 of each clip 1401 of the clippair 1400, and has a double bend shape. The clip pair 1400 may be madefrom any suitable semi-rigid material, including but not limited to anickel titanium shape memory alloy such as nitinol.

In the embodiment as shown in FIG. 14, spring member 1409 will tend tobow downward and fold inward similar to an accordion when the clips 1401are moved to an open position, deforming the spring member 1409 andcausing the spring member 1409 to push on the hooks 1403 to provide arestoring force to bias the clips 1401 towards a closed position.

Referring to FIG. 15, an embodiment of a clip pair 1500 for use with animplant deployment device 100 is illustrated. Clip pair 1500 includestwo clips 1501, each clip 1501 including a hook 1503, similar to theprotruding portion 201 (FIGS. 2A-D) as described above, a body 1505having a locking portion 1507 similar in function to locking tab 202(FIGS. 2A-D) as described above, and a hinge hole 1511 similar to hingehole 133 (FIGS. 2A-D) as described above. The clip pair 1500 alsoincludes a spring member 1509 connecting each clip 1501 together, andconfigured to provide a restoring force to move the clips 1501 from anopen position towards a closed position. The spring member 1509 may takeany suitable shape capable of providing a spring force against the clips1501 when at least one of the hooks 1503 is rotated upward away from theframe arm 1504. As shown in FIG. 15, spring member 1509 is integrallyconnected to a top surface of hooks 1503 of each clip 1501 of the clippair 1500, and has a multiple circuitous bend shape. The clip pair 1500may be made from any suitable semi-rigid material, including but notlimited to a nickel titanium shape memory alloy such as nitinol.

In the embodiment as shown in FIG. 15, spring member 1509 will tend tobow downward and fold inward similar to an accordion when the clips 1501are moved to an open position, deforming the spring member 1509 andcausing the spring member 1509 to push on the hooks 1503 to provide arestoring force to bias the clips 1501 towards a closed position.

Referring to FIG. 16, an embodiment of a clip pair 1600 for use with animplant deployment device 100 is illustrated. Clip pair 1600 includestwo clips 1601, each clip 1601 including a hook 1603, similar to theprotruding portion 201 (FIGS. 2A-D) as described above, a body1605having a locking portion 1607 similar in function to locking tab 202(FIGS. 2A-D) as described above, and a hinge hole 1611 similar to hingehole 133 (FIGS. 2A-D) as described above. The clip pair 1600 alsoincludes a spring member 1609 connecting each clip 1601 together, andconfigured to provide a restoring force to move the clips 1601 from anopen position towards a closed position. The spring member may take anysuitable shape capable of providing a spring force against the clips1601 when at least one of the hooks 1603 is rotated upward away from theframe arm 1604. As shown in FIG. 16, spring member 1609 is integrallyconnected to a top surface of locking portion 1607 or body 1605 of eachclip 1601 of the clip pair 1600, and has W-bend shape. The clip pair1600 may be made from any suitable semi-rigid material, including butnot limited to a nickel titanium shape memory alloy such as nitinol.

In the embodiment as shown in FIG. 16, spring member 1609 will tend tobend outwardly and fold inward when the clips 1601 are moved to an openposition, deforming the spring member 1609 and causing the spring member1609 to pull on the locking portions 1607 to provide a restoring forceto bias the clips 1601 towards a closed position.

Referring to FIG. 17, an embodiment of a clip pair 1700 for use with animplant deployment device 100 is illustrated. Clip pair 1700 includestwo clips 1701, each clip 1701 including a hook 1703, similar to theprotruding portion 201 (FIGS. 2A-D) as described above, a body 1705having a locking portion 1707 similar in function to locking tab 202(FIGS. 2A-D) as described above, and a hinge hole 1711 similar to hingehole 133 (FIGS. 2A-D) as described above. The clip pair 1700 alsoincludes a spring member 1709 connecting each clip 1701 together andconfigured to provide a restoring force to move the clips 1701 from anopen position towards a closed position. The spring member 1709 may takeany suitable shape capable of providing a spring force against the clips1701 when at least one of the hooks 1703 is rotated upward away from theframe arm 1704. As shown in FIG. 17, spring member 1709 is integrallyconnected to a top surface of locking portion 1707 or body 1705 of eachclip 1701 of the clip pair 1700, and has multiple V-bend shape. The clippair 1700 may be made from any suitable semi-rigid material, includingbut not limited to a nickel titanium shape memory alloy such as nitinol.

In the embodiment as shown in FIG. 17, spring member 1709 will tend tobow downward and fold inward similar to an accordion when the clips 1701are moved to an open position, deforming the spring member 1709 andcausing the spring member 1709 to push on the hooks 1703 to provide arestoring force to bias the clips 1701 towards a closed position.

Referring to FIG. 18, an embodiment of a clip pair 1800 for use with animplant deployment device 100 is illustrated. Clip pair 1800 includestwo clips 1801, each clip 1801 including a hook 1803, similar to theprotruding portion 201 (FIGS. 2A-D) as described above, a body 1805having a locking portion 1807 similar in function to locking tab 202(FIGS. 2A-D) as described above, and a hinge hole 1811 similar to hingehole 133 (FIGS. 2A-D) as described above. The clip pair 1800 alsoincludes a spring member 1809 connecting each clip 1801 together, andconfigured to provide a restoring force to move the clips 1801 from anopen position towards a closed position. The spring member 1809 may takeany suitable shape capable of providing a spring force against the clips1801 when at least one of the hooks 1803 is rotated upward away from theframe arm 1804. As shown in FIG. 18, spring member 1809 is integrallyconnected to a top surface of locking portion 1807 or body 1805 of eachclip 1801 of the clip pair 1800, and has a multiple attenuatedcurve-style bend shape. The clip pair 1800 may be made from any suitablesemi-rigid material, including but not limited to a nickel titaniumshape memory alloy such as nitinol.

In the embodiment as shown in FIG. 18, spring member 1809 will tend tobend outwardly and upward when the clips 1801 are moved to an openposition, deforming the spring member 1809 and causing the spring member1809 to pull on the locking portions 1807 to provide a restoring forceto bias the clips 1801 towards a closed position.

Referring to FIG. 19, an embodiment of a clip pair 1900 for use with animplant deployment device 100 is illustrated. Clip pair 1900 includestwo clips 1901, each clip 1901 including a hook 1903, similar to theprotruding portion 201 (FIGS. 2A-D) as described above, a body 1905having a locking portion 1907 similar in function to locking tab 202(FIGS. 2A-D) as described above, and a hinge hole 1911 similar to hingehole 133 (FIGS. 2A-D) as described above. The clip pair 1900 alsoincludes a spring member 1909 connecting each clip 1901 together, andconfigured to provide a restoring force to move the clips 1901 from anopen position towards a closed position. The spring member 1909 may takeany suitable shape capable of providing a spring force against the clips1901 when at least one of the hooks 1903 is rotated upward away from theframe arm 1904. As shown in FIG. 19, spring member 1909 is integrallyconnected to a top surface of locking portion 1907 or body 1905 of eachclip 1901 of the clip pair 1900, and has a double bend that causes thespring member 1909 to bend laterally relative to the clips 1901 andprotrude out of a plane defined by a rotational motion of clips 1901. Assuch, the spring member 1909 may be shaped to deform in three dimensionsin any suitable manner. Accordingly, any other suitable spring membershape, including but not limited to embodiments disclosed herein, may beutilized in conjunction with one or more transverse or three dimensionalbends. The clip pair 1900 may be made from any suitable semi-rigidmaterial, including but not limited to a nickel titanium shape memoryalloy such as nitinol.

In the embodiment as shown in FIG. 19, the spring member 1909 includesleg portions 1921 and an arcuate portion 1923. As the clip 1901 isrotated from the closed position to the open position, the leg portions1921 will rotate inwardly and compress the arcuate portion 1923 suchthat the arcuate portion 1923 tends to fold in the transverse directionwhen the clips 1901 are moved to an open position, thus deforming thespring member 1909 and causing the spring member 1909 to push on thehooks 1903 or body portion 1905 to provide a restoring force to bias theclips 1901 towards a closed position.

Another embodiment of a lock bar 203 a is depicted in FIG. 20. Lock bar203 a may be substituted for lock bar 203 in implant deployment device100. As shown, lock bar 203 a includes protrusions 209 a, 209 b formedfrom or attached to lock bar 203 a that extend at least partially awayfrom the lock bar 203 a in a lateral direction that is away from theframe arm 104. Each protrusion 209 a, 209 b may be a tab of materialthat is cut out of the lock bar 203 a and bent outwardly to create aramp-like cammed shaped as shown in FIG. 20. Each protrusion 209 a, 209b may also be a separate piece permanently or releasably attached to thelock bar 203 a.

Each protrusion 209 a, 209 b acts to block rotation of the clips in eachclip pair when the lock bar 203 a is moved to a locked position beneaththe clips of the clip pair (FIGS. 21B and 21C). Also, each protrusion209 a, 209 b allows for the clips of the clip pair to be assembled in anopen position and selectively held in the open position (FIG. 21B) tofacilitate attachment of a surgical implant 210 (FIG. 3A) over the clipsand against the frame arm 104.

Referring initially to FIG. 21A, the frame arm 104 includes the lock bar203 a and the clip pair 800 that was previously discussed in detail withreference to FIG. 8. Although the lock bar 203 a is described withrespect to the clip pair 800, the lock bar 203 a is also usable withother embodiments of the clip pairs that were previously discussed indetail hereinabove. In FIG. 21A, the lock bar 203 a is shown in anunlocked position and the clip pair 800 is shown in the closed position.The clips 801 of the clip pair 800 are rotatable to the open position,as seen in FIG. 21B, which allows the clinician to attach the surgicalimplant 210 (FIG. 3A) to the frame arm 104 by passing the surgicalimplant 210 over the hooks 803 of the clips 801. This is the defaultconfiguration for the implant deployment device 100 since it allows theclinician to attach the surgical implant 210 to the implant deploymentdevice 100 since the clips of the clip pair are maintained in the openposition due to the interaction with the clips 801 of the clip pair 800and the lock bar 203 a in the locked position (FIG. 21B). Once thesurgical implant 210 is abutting the frame arm 104, the clips 801 of theclip pair 800 are rotated to the closed position over the protrusions209 a, 209 b of the lock bar 203 a as shown in FIG. 21C. With the clips801 in the closed position and the lock bar 203 a in the lockedposition, the locking portions 807 of the clips 801 contact uppersurfaces of the protrusions 209 a, 209 b of the lock bar 203 a, therebymaintaining the clips 801 in the closed position.

With continued reference to FIGS. 21A-C, deployment of the surgicalimplant 210 will be described below. Although FIGS. 21A-C show the clippair 800, other disclosed clip pairs may be readily substituted for clippair 800 with the same results. After the surgical implant 210 has beenattached to the frame arm 104, the user may rotate the clips 801 to theclosed position.

With the clips 801 in a closed position and the lock bar 203 a in thelocked position (FIG. 21B), the clips 801 secure the surgical implant210 against the frame arm 104 substantially similar to what is shown inFIGS. 3C and 3D. When deployment is desired, the clinician places thesurgical implant 210 at a desired location in a surgical site andaffixes the surgical implant 210 to tissue using known surgicaltechniques. Subsequently, the clinician activates a release button (notshown) on the implant deployment device 100, which transitions the lockbar 203 a from the locked position (FIG. 21C) to the unlocked position(FIG. 21A). With the lock bar 203 a in the unlocked position, theclinician moves the implant deployment device 100 away from the surgicalimplant 210 that is affixed to tissue. Since the lock bar 203 a is inthe unlocked position, the clips 801 rotate to the open position as theimplant deployment device 100 is moved away from the attached surgicalimplant 210. Once the implant deployment device 100 is separated fromthe attached surgical implant 210, the spring member 809 urges the clips801 towards the closed position. Once the clips 801 are in the closedposition, the clinician removes the implant deployment device 100 fromthe surgical site.

It would be readily apparent to one having ordinary skill in the artthat the specific shape and method/points of connection of the springmembers as described herein may be combined in any suitable manner, andalso includes any suitable shapes and connections not herein explicitlydescribed.

The spring constant of any of the herein described spring members may beselected as a function of shape, thickness, size, material selection,etc., of the individual spring members. The spring constant of thespring members may be selected such that the clips may be pulled to anopen position from the closed position by a clinician to help remove orreload a mesh or surgical implant onto the hooks. The spring constant ofthe spring members may be such that clinician may pull on a surgicalmesh that is compressed by the clip pairs against one or more framearms, and, without tearing or damaging the mesh, the clips rotate to theopen position.

Utilizing one or more embodiments of clip pairs as herein disclosedcauses a biasing to the clips such that the hook portions of the clipstend to push up against the frame arm and hold down any mesh attachedthereto. The clips may be initially locked in an open position allowinga clinician to force the hooks through a surgical implant such as asurgical mesh. After the implant has been communicated with the hooks,the clinician may release the lock allowing the spring member to forceeach clip into a downward or locked state, thereby compressing thesurgical implant against the one or more frame arms. When deployment isdesired, the clinician may position the clips into the open positionagainst the force of each spring member, thereby allowing the surgicalimplant to be removed from the hooks. After the implant is removed andplaced at a desired surgical site, the clinician may then allow thespring members to return the clips to the downward or locked state suchthat the clinician may then remove the deployment device from thepatient.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The foregoingembodiments are therefore to be considered in all respects illustrativerather than limiting on the invention described herein. Scope of theinvention is thus indicated by the appended claims rather than by theforegoing description, and all changes which come within the meaning andrange of equivalency of the claims are therefore intended to be embracedtherein.

What is claimed is:
 1. A system for closing an aperture in a biologicaltissue, the system comprising: a proximal portion adapted to remainoutside the body; a distal portion adapted to be inserted into the body,the distal portion including at least one frame arm; and a clip assemblyincluding at least one clip pair connected to the at least one frame armand configured to releasably retain a surgical implant, wherein eachclip pair includes two clips, each clip including a hook, a body, ahinge hole, and at least one spring member integrally connected to eachclip, wherein the spring member biases each clip from an open positiontowards a closed position.
 2. The system of claim 1, wherein the atleast one spring member is integrally connected to the hook.
 3. Thesystem of claim 1, wherein the at least one spring member is integrallyconnected to the body.
 4. The system of claim 1, wherein each clipfurther includes a locking tab or locking portion, wherein the at leastone spring member is integrally connected to the locking tab or lockingportion.
 5. The system of claim 1, wherein the at least one springmember includes a single bend shape.
 6. The system of claim 1, whereinthe at least one spring member includes a multiple bend shape.
 7. Thesystem of claim 1, wherein the at least one spring member existsentirely in a plane defined by a rotation of the clips.
 8. The system ofclaim 1, wherein the at least a portion of the at least one springmember exists outside a plane of rotation of the clips.
 9. The system ofclaim 1, wherein at least one clip is made of nitinol.
 10. A clip systemfor releasably retaining a mesh to an implant deployment device,comprising: at least one clip pair connectable to the implant deploymentdevice and configured to releasably retain a surgical implant, whereineach clip pair includes two clips, each clip including a hook, a body, ahinge hole, and at least one spring member integrally connected to eachclip, wherein the spring member biases each clip from an open positiontowards a closed position.
 11. The system of claim 10, wherein the atleast one spring member is integrally connected to the hook.
 12. Thesystem of claim 10, wherein the at least one spring member is integrallyconnected to the body.
 13. The system of claim 10, wherein each clipfurther includes a locking tab or locking portion, wherein the at leastone spring member is integrally connected to the locking tab or lockingportion.
 14. The system of claim 10, wherein the at least one springmember includes a single bend shape.
 15. The system of claim 10, whereinthe at least one spring member includes a multiple bend shape.
 16. Thesystem of claim 10, wherein the at least one spring member existsentirely in a plane defined by rotation of the clips.
 17. The system ofclaim 10, wherein the at least a portion of the at least one springmember exists outside a plane of rotation of the clips.
 18. The systemof claim 10, wherein at least one clip is made of nitinol.
 19. A clipsystem for releasably retaining a mesh to an implant deployment device,comprising: at least one clip pair connectable to the implant deploymentdevice and configured to releasably retain a surgical implant, whereineach clip pair includes two clips, each clip including a hook, a body, ahinge hole, and a spring member integrally connected to each clip,wherein the spring member is integrally connected to the hook on eachclip, wherein the spring member biases each clip from an open positiontowards a closed position.
 20. The system of claim 19, wherein the clippair comprises nitinol.
 21. A method for deploying a surgical implant ata target site, comprising: providing at least one surgical implantdeployment device including at least one clip pair connectable to thesurgical implant deployment device and configured to releasably retain asurgical implant, wherein each clip pair includes two clips, each clipincluding a hook, a body, a hinge hole, and a spring member integrallyconnected to each clip, wherein the spring member biases each clip froman open position towards a closed position; attaching a surgical implantto the surgical implant deployment device when the clips are in an openposition; and allowing the spring member to force each clip into aclosed position thereby compressing the surgical implant to the surgicalimplant deployment device.
 22. The method of claim 21, furthercomprising inserting at least a portion of the surgical implantdeployment device into an opening in tissue.
 23. The method of claim 22,further comprising separating the surgical implant from the at least oneclip pair by moving the surgical implant device relative to the implantdeployment device.